September 1, 2010: GW Pharmaceuticals plc and Bayer Inc have announced that Health Canada has approved Sativex® (delta-9-tetrahydrocannabinol 27 mg/ml and cannabidiol 25 mg/ml) as adjunctive treatment for symptomatic relief of spasticity in adult patients with multiple sclerosis (MS). Sativex is the first cannabinoid medicine derived from whole plant extracts from the cannabis sativa plant containing both delta-9-tetrahydrocannabinol and cannabidiol. This means that people in Canada with MS experiencing the debilitating symptoms of spasticity, such as painful spasms and cramps, will now have a new treatment option in addition to standard therapy.
The MS spasticity indication has received a full marketing authorisation, or Notice of Compliance (NOC), from Health Canada. Sativex is useful as adjunctive treatment for symptomatic relief of spasticity in adult patients with MS who have not responded adequately to other therapy and who demonstrate meaningful improvement during an initial trial of therapy. In addition to this new NOC, Health Canada approved Sativex in 2005 under its Notice of Compliance with Conditions (NOC/c) policy as adjunctive treatment for the symptomatic relief of neuropathic pain in adult patients with multiple sclerosis, and granted a further NOC/c approval in 2007 as adjunctive analgesic treatment in adult patients with advanced cancer who experience moderate to severe pain during the highest tolerated dose of strong opioid therapy for persistent background pain.
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